phase ii clinical study of pyrotinib in first-line treatment of primary her2-amplified/mutated advanced non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: this is a multicenter, single-arm phase ii clinical study to evaluate the safety and efficacy of pyrotinib maleate as a first-line treatment for her2-mutated or amplified non-small cell lung cancer. pyrotinib maleate is a small molecule tyrosine kinase inhibitor that can irreversibly inhibit her1, her2, and her4.


Eligibility criteria:
inclusion criteria: * 1. age: ≥18 years old; 2. histologically confirmed stage iiib or iv non-small cell lung cancer; 3. have not previously received systemic anticancer therapy for stage iiib or iv nsclc; 4. her2 insertion mutation, primary her2 point mutation or primary her2 amplification confirmed by genetic testing of tumor tissue or blood, pleural effusion, cerebrospinal fluid and other specimens; 5. there is at least one measurable lesion determined based on recist 1.1; 6. ecog score 0-1 points; 7. expected survival period ≥ 12 weeks; 8. cardiac ultrasound examination showed that left ventricular ejection fraction (lvef) ≥ 50%; 9. the patient's bone marrow function, liver and kidney function were confirmed to meet the following requirements by laboratory tests before the first administration: 1. neutrophil count (anc) ≥ 1,500/mm3 (1.5×109/l); 2. platelet count (plt) ≥ 75,000/mm3 (75×109/l); 3. hemoglobin (hb) ≥ 8 g/dl (80 g/l); 4. serum creatinine (scr) ≤ 1.5 times the upper limit of normal (uln) or creatinine clearance ≥ 60 ml/min; 5. total bilirubin (tbil) ≤ 1.5 times the upper limit of normal (uln); 6. aspartate aminotransferase (ast) or alanine aminotransferase (alt) level ≤ 2.5 times the upper limit of normal (uln), patients with liver metastases should be ≤ 5×uln. 10. the subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up. exclusion criteria: * 1. previous use of egfr tki therapy; 2. participated in clinical trials of other drugs within 4 weeks before the start of the study; 3. symptomatic brain metastases or meningeal metastases; 4. insufficient bone marrow reserve or insufficient organ function; 5. refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow drugs, etc., may affect the intake, transport or absorption of drugs; 6. received major surgical operation or severe traumatic injury, fracture, or poor healing wound within 4 weeks; 7. known history of other malignancies, unless the subject has received potentially curative therapy prior to initiation of therapy and has at least 3 years of evidence of disease-free recurrence (non-small cell lung cancer, radical skin basal cell undergoing successful resection) carcinoma, superficial bladder cancer, squamous cell carcinoma of the skin, cervical carcinoma in situ or other carcinoma in situ); 8. those who have serious adverse reactions and allergies to the drugs and excipients used in this group; 9. pregnant or lactating female patients, female patients with fertility and positive baseline pregnancy test, or patients of childbearing age who are unwilling to take effective contraceptive measures throughout the trial; 10. the patient has serious concomitant diseases, or any other condition that the investigator considers the patient unsuitable to participate in this study.